7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
SPLIT SEAT POSITIONING CHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
GEN_3
FDA 510(k)
FDA Class 1
·Physical Medicine
CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT
FDA 510(k)
FDA Class 2
·General Hospital
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 30, 2014
ACTIVA
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code MHY·November 21, 2012
MATRIX DETACHABLE COILS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code HCG·September 22, 2010
Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 13, 2014